Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children

Skin Wound Clinical Trial

Official title:
A Phase II, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Full-Thickness Defects in Adults and Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)

Status Active, not recruiting

Clinical Trial Summary

This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.

Clinical Trial Description

This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. scar quality, in comparison to meshed STSG. ;

Study Design

Related Conditions & MeSH terms

Skin Wound

Clinical Trial Details

NCT number	NCT03394612
Study type	Interventional
Source	CUTISS AG
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	February 14, 2018
Completion date	December 2026

View Details

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